Health Monitoring Apparatus and Methods

ABSTRACT

A measurement module for glucose testing includes a glucose testing measurement module housing, a test strip receptacle formed in the housing, and a connector portion formed in the housing and shaped to permit mechanical removable attachment of the housing to a hand-held computer. Electronics determine the amount of glucose present in a sample of body fluid, when the test strip is positioned in the receptacle and the body fluid is placed on a test strip, and communicate the glucose amount to the hand-held computer via the connector portion.

This application is a continuation patent application of U.S. patentapplication Ser. No. 10/112,671, filed Mar. 29, 2002, which claims thebenefit of priority to U.S. provisional patent applications No.60/300,011, filed Jun. 20, 2001, and 60/280,905, filed Apr. 2, 2001,which are assigned to the same assignee as the present application andare hereby incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to blood glucose monitoring, and particularly to ablood glucose monitor and data management and display device integratedas a synchronous, handheld unit, as an effective and efficient diabetesmanagement tool.

2. Discussion of the Related Art

Blood glucose self-measurements have been conventionally taken bydiabetics. The diabetic uses a blood glucose measuring tool. Thediabetic typically pricks his or her finger using a lancet. A droplet ofexposed blood is applied to a sensor strip which is placed in theglucose measuring tool. A reading appears on a display of the measuringtool indicating the blood glucose level of the diabetic.

Diabetics sometimes use a computer having some form of software thatpermits the user to track the glucose measurements they have taken. Theglucose measurements are typically loaded into the computer manually bythe diabetic. Other transfer methods are possible that require steps bythe diabetic in order that the information gets entered into thecomputer, e.g., transferring glucose readings that have been retained inmemory of the measuring tool via a cable to the computer. The data maybe sent to a health care professional who may also be keeping an eye onthe diabetic's status. It is an object of this invention to provide amore efficient and reliable process of taking the measurement,determining the glucose level, entering the glucose level data into adiabetes management program, and managing the diabetes condition usingdiabetes management software.

In the past, the glucose measurement tool could be carried by thepatient for use almost anywhere. However, access to data entry andmanagement using the computer and software have been relegated to a PCsetup at a fixed location such as the patient's home, and so these stepshad to wait until the diabetic arrived back at his or her home. In thepresent invention, it is recognized that the development of hand-helddevices such as PDAs and mobile phones and PDA/mobile phone combinedunits could permit diabetics to enter data and use the data managementsoftware away from their PCs. It is therefore an object of thisinvention to provide a system that permits data entry and management bythe diabetic away from the diabetic's PC. In addition, it is desired tohave a device that permits this mobile data entry and management, andyet permits the user to take off-finger measurements, or using so-calledalternate site testing.

Conventional methods have utilized two very separate instruments, theglucose measurement tool and the PC. It is an object of this inventionto provide a synchronous tool that performs the conventional functionsof both the glucose measurement tool and PC, and perhaps additionalfeatures and advantages. It is a further object to synergisticallyprovide this tool, such as by using a same power source and/or a samedisplay for both purposes, i.e., glucose measurement and data managementand/or analysis.

SUMMARY OF THE INVENTION

In view of the above, and in particular accordance with the aboveobjects, a measurement module for glucose testing is provided includinga glucose testing measurement module housing, a test strip receptacleformed in the housing, and a connector portion formed in the housing andshaped to permit mechanical, removable attachment of the housing to ahand-held processing device, hand-held computer, PDA, mobile phone orwireless processing device. Electronics are provided either in themeasurement module or in the hand-held processing device for determiningthe amount of glucose present in a sample of body fluid, when a teststrip is positioned in the receptacle and the fluid is placed on thetest strip, and for communicating the glucose amount to the processingdevice via the connector portion.

The test strip is typically inserted into the test strip receptacle sothat the system may calibrate in preparation for application of the bodyfluid to the strip. Insertion of the strip may further initiate anactivation of electrical components that participate in the testing of abody fluid sample. When the system is ready after connecting themeasurement module with the hand-held processing device, and afterinsertion of the strip into the receptacle in the measurement module,and after any calibration or component activation, then the systemdisplay preferably indicates that the body fluid is to be now applied tothe strip for testing. An alternative system may be or may becomeavailable to those skilled in the art wherein the body fluid is appliedto the strip, and/or calibration/component activation occur, beforestrip insertion, and if such system would otherwise include one or morefeatures of preferred embodiments herein, then such systems may also bewithin the scope of a preferred embodiment.

The housing of the glucose testing measurement module is configured sothat a sample of body fluid may be easily applied to the strip when themodule is connected to the hand-held processing device and the strip isinserted into the receptacle in the measurement module. The end of thehousing from which the strip protrudes is substantially narrowedcompared with the end that connects with the hand-held processingdevice. This narrowed end is preferably a tapered trapezoidal profile,is preferably rounded in two or three directions, protrudes from theconnector end defining a shoulder or inset particularly for matching analternate site body contour and is preferably made of low durometermaterial, so that the module can rest comfortably and securely on a bodylocation near the test site for easy and precise application of the bodyfluid to the strip. This configuration of the housing is particularlyadvantageous when off-finger or alternate site testing is desired suchas at an arm or a leg site.

The test strip may be side-filled and may also be tip-filled. Use of aside-filled strip is particularly advantageous for alternate sitetesting. For example, the module may be rested near the alternate testsite (for example a forearm) with a user contacting a rounded shoulderof the housing on the user's skin. The device is then rocked comfortablyinto a test strip side-fill contact position with the body fluid, due tothe ergonometric and/or arthopometric design of the module. For thispurpose the module preferably has no square or sharp edges exposed whenfitted with the handheld processing device. Even when using a tip-filledstrip, exposed edges of the module are preferably rounded for rockingthe strip into tip-filled contact with the body fluid, even though thedepth of the module is small compared with its width particularly at thewider connection end, and contact with the user may be establishedperhaps only at a single point on the narrowed end when the body fluidin applied to the strip. The test strip advantageously uses only arelatively small amount of body fluid sample for performing reliabletests, such as less than 1 microliter. Measurements are conductedpreferably using a coulometric technique, and alternatively anamperometric, reflectrometic or other technique understood by thoseskilled in the art, which is significant for alternate site testingwherein typically a lower volume of sample is made available by a samelancing operation at an alternate site than when testing is performed onthe finger.

The removable connectability of the measurement module with thehand-held processing device is greatly facilitated by electronics thatintegrate the two components of this integrated system. An isolationbarrier is provided for safe glucose monitoring and/or analysis, eventhough power is preferably supplied to the module from the hand-heldprocessing device, while also data is transferred between themeasurement module and hand-held processing device. The power ispreferably transformer-coupled, or alternatively capacitatively-coupled,between the isolated and non-isolated sides of the barrier. Analogfront-end signal acquisition circuitry of the measurement module allowssignals including data indicative of a blood glucose level or other testof the body fluid to be acquired by the measurement module.Opto-isolators preferably isolate data I/O circuitry and provide a datasignal transport route across the barrier to the hand-held processingdevice so that the data can be analyzed there and/or easily uploaded toa PC by HotSync. By “HotSync”, what is meant is any method ofsynchronizing data in the handheld with data in a PC, such as by cable,cradle, infrared or radio link. By “analyze”, it is meant that thehand-held processing device can do more than merely display a glucosemeasurement value. For example, charts, plots and graphs of compiledglucose data can be generated and additional factors such as diet,exercise, insulin regimen, etc., may be used to process and/or displayvarious information relating to a diabetic condition or regimen. Serialto parallel conversion circuitry permits parallel access to adata/address bus of the hand-held processing device to the datatransported across the barrier.

In a particular embodiment, a measurement module for glucose testing isfurther provided including a test strip receptacle in a glucosemeasurement module, a connector portion formed in the module shaped topermit connection of the module to a hand-held computer by inserting theconnector portion of the glucose measurement module into a receptacledefined within the hand-held computer, and electronics for determiningthe amount of glucose present in a sample of body fluid, when the fluidis placed on a test strip and the test strip is positioned in thereceptacle, and for communicating the glucose amount to the hand-heldcomputer via the connector portion.

A glucose monitoring apparatus is further provided including ameasurement module configured to couple with a test sensor and ahand-held processing device electrically and mechanically coupled withthe measurement module to form an integrated, hand-held unit forperforming and analyzing a glucose measurement after the test sensor iscoupled with the measurement module and body fluid is applied to thetest sensor.

A further glucose monitoring apparatus is provided including ameasurement module configured to couple with a test sensor and ahand-held processing device electrically and mechanically coupled withand separable from the measurement module to form an integrated,hand-held unit for performing and analyzing a glucose measurement afterthe test sensor is coupled with the measurement module and body fluid isapplied to the test sensor.

A glucose monitoring apparatus is also provided including a measurementmodule configured to couple with a test sensor and a hand-heldprocessing device configured to receive data transmission from themeasurement module. The measurement module and processing device form asynchronous unit for performing and analyzing a glucose measurementafter the test sensor is coupled with the measurement module and bodyfluid is applied to the test sensor. The monitoring apparatus includes asingle display at the processing device.

A glucose monitoring apparatus is further provided including ameasurement module not having a display for displaying results ofglucose measurements, the module being configured to couple with a testsensor, and a hand-held processing device configured to receive datatransmission from the measurement module. The measurement module and theprocessing device form a synchronous unit for performing and analyzing aglucose measurement after the test sensor is coupled with themeasurement module and body fluid is applied to the test sensor. Theprocessing device includes a display for displaying the results of saidglucose measurements.

A glucose monitoring apparatus is further provided including ameasurement module configured to couple with a test sensor and ahand-held processing device configured to receive a data transmissionfrom the measurement module. The measurement module and processingdevice form a synchronous unit for performing and analyzing a glucosemeasurement. The processing device is configured for automaticallyreceiving the data transmission after the test sensor is coupled withthe measurement module and body fluid is applied to the test sensor.

A method of performing a glucose measurement using a measurement moduleand a hand-held processing device is provided including coupling theprocessing device electrically and mechanically with the measurementmodule to form an integrated, hand-held unit for performing andanalyzing a glucose measurement after a test sensor is inserted into themeasurement module, coupling the test sensor with the measurementmodule, applying body fluid to the test sensor and reading a glucoselevel from a display on the integrated hand-held unit.

A method of performing a glucose measurement using a measurement moduleand a hand-held processing device is also provided including couplingthe processing device with the measurement module to receive a datatransmission from the measurement module such that the measurementmodule and the processing device form a synchronous unit including asingle display on the processing device for performing and analyzing aglucose measurement after a test sensor is inserted into the measurementmodule, coupling the test sensor with the measurement module, applyingbody fluid to the test sensor and reading a body fluid glucose levelfrom the display on the processing device.

A method of performing a glucose measurement using a measurement moduleand a hand-held processing device, is further provided includinginserting the measurement module into a receptacle defined within theprocessing device for the processing device to receive a datatransmission from the measurement module, such that the measurementmodule and the processing device form an integrated, hand-held unit forperforming and analyzing a glucose measurement after a test sensor isinserted into the measurement module, coupling the test sensor with themeasurement module, applying body fluid to the test sensor and reading aglucose level from a display on the processing device.

The invention further includes a method of performing a glucosemeasurement using a measurement module and a hand-held processing deviceincluding coupling the processing device with the measurement module toautomatically receive a data transmission from the measurement moduleafter a test sensor is inserted into the measurement module, such thatthe measurement module and the processing device form a synchronous unitfor performing and analyzing a glucose measurement, coupling the testsensor with the measurement module, applying body fluid to the testsensor and reading a glucose level from a display.

A glucose monitoring apparatus is further provided including ameasurement module configured to couple with a test sensor, and ahand-held processing device electrically and mechanically coupled withthe measurement module to form an integrated, hand-held unit forperforming and analyzing a glucose measurement after the test sensor isinserted and body fluid is applied to the test sensor. The measurementmodule is further geometrically configured to enable off-finger oralternate site application of blood to the test strip.

A glucose monitoring apparatus is also provided including a measurementmodule configured to couple with a test sensor, and a hand-heldprocessing device electrically and mechanically coupled with themeasurement module to form an integrated, hand-held unit for performingand analyzing a glucose measurement after the test sensor is insertedand body fluid is applied to the test sensor. The measurement module isrounded in three dimensions for providing smooth off-finger or alternatesite points of contact with the skin of a person being tested.

A glucose monitoring apparatus is further provided including ameasurement module configured to couple with a test sensor, and ahand-held processing device electrically and mechanically coupled withthe measurement module to form an integrated, hand-held unit forperforming and analyzing a glucose measurement after the test sensor isinserted and body fluid is applied to the test sensor. The measurementmodule is rounded in at least two dimensions for providing smoothoff-finger or alternate site points of contact with the skin of a personbeing tested.

A glucose monitoring apparatus is also provided including a measurementmodule configured to couple with a test sensor, and a hand-heldprocessing device electrically and mechanically coupled with themeasurement module to form an integrated, hand-held unit for performingand analyzing a glucose measurement after the test sensor is insertedand body fluid is applied to the test sensor. The measurement moduleincludes a telescoping trapezoidal profile for permitting placement of atest strip inserted within the module at an off-finger or alternate sitelocation of a person being tested.

A glucose monitoring apparatus is also provided including a measurementmodule configured to couple with a test sensor, and a hand-heldprocessing device electrically and mechanically coupled with themeasurement module to form an integrated, hand-held unit for performingand analyzing a glucose measurement after the test sensor is insertedand body fluid is applied to the test sensor. The measurement moduleincludes an encapsulation port for the test sensor and a PC boardincluding an opto-isolation component. The measurement module extendsless than two inches in length and less than one half inch in thicknessbeyond dimensions of the wireless processing device.

A software program for analyzing glucose data measured with a glucosemonitoring apparatus which includes a measurement module configured tocouple with a test sensor and a hand-held processing device is furtherprovided. The measurement module and processing device form asynchronous unit for performing and analyzing a glucose measurementafter the test sensor is inserted and body fluid is applied to the testsensor. The processing device is configured to HotSync with a PC. Thesoftware program includes instructions for a processor to perform thesteps of creating a replica database on the PC of the glucose datastored in a device database on the processing device, and synchronizingthe glucose data to a PC database program. The synchronizing stepincludes reading the glucose data stored in the device database on theprocessing device, matching the data to corresponding data in thereplica database, format converting the data and writing the data to thereplica database.

A software program for analyzing glucose data measured with a glucosemonitoring apparatus which includes a measurement module configured tocouple with a test strip and a hand-held processing device is alsoprovided. The measurement module and processing device form asynchronous unit for performing and analyzing a glucose measurementafter the test strip is inserted and body fluid is applied to the teststrip. The processing device is configured to HotSync with a PC. Thesoftware program includes instructions for a processor to perform thesteps of measuring glucose data from the test strip having body fluidapplied thereto, automatically downloading the glucose data from themeasurement module to the processing device, and downloading the glucosedata to a personal computer.

A method for analyzing glucose data measured with a glucose monitoringapparatus which includes a measurement module configured to couple witha test sensor and a hand-held processing device. The measurement moduleand processing device form a synchronous unit for performing andanalyzing a glucose measurement after the test sensor is inserted andbody fluid is applied to the test sensor. The processing device isconfigured to HotSync with a PC. The method includes creating a replicadatabase on the PC of the glucose data stored in a device database onthe processing device, and synchronizing the glucose data to a PCdatabase program. The synchronizing step includes reading the glucosedata stored in the device database on the processing device, matchingthe data to corresponding data in the replica database, formatconverting the data, and writing the data to the replica database.

A method for analyzing glucose data measured with a glucose monitoringapparatus which includes a measurement module configured to couple witha test strip and a hand-held processing device is also provided. Themeasurement module and processing device form a detachably integrated,hand-held unit for performing and analyzing a glucose measurement afterthe test strip is inserted and body fluid is applied to the test strip.The processing device configured to HotSync with a PC. The methodincludes measuring glucose data from the test strip having body fluidapplied thereto, automatically downloading the glucose data from themeasurement module to the processing device after measuring said glucosedata, and downloading the glucose data to a personal computer.

A software program for analyzing glucose data measured with a glucosemonitoring apparatus which includes a measurement module configured tocouple with a test sensor and a hand-held processing device is furtherprovided. The measurement module and processing device form asynchronous unit for performing and analyzing a glucose measurementafter the test sensor is inserted and body fluid is applied to the testsensor. The software program includes instructions for a processor toperform the steps of measuring glucose data, providing a sensory outputof a glucose level corresponding to the data, and automatically enteringthe data into a database accessible by a diabetes management softwareprogram.

A method for analyzing glucose data measured with a glucose monitoringapparatus which includes a measurement module configured to couple witha test sensor and a hand-held processing device. The measurement moduleand processing device form a detachably integrated, hand-held unit forperforming and analyzing a glucose measurement after the test sensor isinserted and body fluid is applied to the test sensor. The methodincludes measuring glucose data, providing a sensory output of a glucoselevel corresponding to the data, and automatically entering the datainto a database accessible by a diabetes management software program.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 schematically shows a plan view of an integrated glucosemeasurement module and hand-held processing device, such as a personaldigital assistant or PDA, or mobile phone, integrated phone and PDA, orother wireless device, according to a preferred embodiment.

FIG. 2 shows a block diagram of electrical modules of the integratedglucose measurement module and PDA of FIG. 1.

FIGS. 3 a and 3 b schematically illustrate an advantageous electricalisolation barrier feature of an integrated module and PDA according to apreferred embodiment.

FIG. 4 shows an electrical circuitry schematic of a glucose measurementmodule for integrating with a PDA according to a preferred embodiment.

FIG. 5 shows an electrical circuitry schematic of a PDA for integratingwith a glucose measurement module according to a preferred embodiment.

FIG. 6 a schematically shows a bottom plan view of a glucose measurementmodule for integrating with a PDA according to a preferred embodiment.

FIG. 6 b schematically shows a rear view of the glucose module of FIG. 6a.

FIG. 6 c schematically shows a bottom perspective view of the glucosemodule of FIG. 6 a.

FIG. 6 d schematically shows a top perspective view of the glucosemodule of FIG. 6 a.

FIG. 6 e schematically shows a side view of the glucose module of FIG. 6a.

FIG. 6 f schematically shows a front view of the glucose module of FIG.6 a.

FIG. 6 g schematically shows another side view of the preferred glucosemodule with preferred dimensions shown in millimeters.

FIG. 6 h schematically shows a top view of the preferred glucose modulewith preferred dimensions shown in millimeters.

FIG. 6 i schematically shows another rear view of the preferred glucosemodule with preferred dimensions shown in millimeters.

FIG. 7 a schematically shows a side view of the measurement module ofFIG. 6 a integrated with a PDA according to a preferred embodiment.

FIG. 7 b schematically shows a plan view of the integrated measurementmodule and PDA of FIG. 7 a.

FIG. 8 illustrates a glucose data handling system software according toa preferred embodiment in block diagram form.

FIG. 9 illustrates a hardware/software block diagram of an integratedglucose measurement module and PDA according to a preferred embodiment.

FIG. 10 shows a data flow diagram of an integrated glucose measurementmodule and PDA according to a preferred embodiment.

FIG. 11 shows a software data flow diagram of an integrated glucosemeasurement module and PDA according to a preferred embodiment.

FIG. 12 illustrates a line graph of blood glucose data generated by anintegrated measurement module and PDA according to a preferredembodiment.

FIG. 13 illustrates pie charts of blood glucose data generated by anintegrated measurement module and PDA according to a preferredembodiment.

INCORPORATION BY REFERENCE

What follows is a cite list of references each of which is, in additionto the background, the invention summary, the abstract and the claims,hereby incorporated by reference into the detailed description of thepreferred embodiments below, as disclosing alternative embodiments ofelements or features of the preferred embodiments not otherwise setforth in detail below. A single one or a combination of two or more ofthese references may be consulted to obtain a variation of the preferredembodiments described in the detailed description below. Further patent,patent application and non-patent references are cited in the writtendescription and are also incorporated by reference into the preferredembodiment with the same effect as just described with respect to thefollowing references:

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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 schematically shows a perspective view of an integrated glucosemeasurement module 2 and a hand-held processing device 4, such aspreferably a personal digital assistant (PDA) 4 or a mobile phone orcombined PDA/phone or other wireless device with a processor as may beunderstood by those skilled in the art. Hereinafter when the term PDA isused it is meant to refer to any of these or other hand-held processingdevices, any of which may also be operated using hands-free accessoriesand/or equipment. The glucose measurement module 2 (hereinafter “module2”) is shown in FIG. 1 mechanically attached to the PDA 4. The module 2is in this way physically mounted to and integrated with the PDA 4. Themodule 2 is also electrically connected to the PDA 4 when mounted intothe PDA 4. In addition, the module 2 is software interfaced with the PDA4 when mounted into the PDA 4. The module 2 shown in FIG. 1 preferablydoes not have a display, since the display of the PDA 4 may be used fordisplaying information. The PDA 4 may be replaced by another processingdevice having a display such as a mobile phone having a connector forattaching the module 2.

The module is shown having a slot 6 for insertion of an in vitro teststrip 8. Some details may be found at U.S. patent application Ser. No.09/413,565, which is assigned to the same assignee as the presentapplication and is hereby incorporated by reference. When the test strip8 is inserted into the slot 6, preferably blood such as whole blood,plasma and/or serum, and alternatively another body fluid such asinterstitial fluid, sweat, urine, tears, saliva, dermal fluid, spinalfluid, etc., is applied to the strip 8 and the module 2 measures theglucose level of the body fluid applied to the strip 8. Hereinafter,whenever blood or body fluid is referred to for being applied to thestrip 8, it is meant to include whatever body and/or biological fluidthat may be applied to strip 8 for testing. The glucose level dataautomatically transfers to the PDA 4 (the data transfer mechanism isdescribed in more detail below with reference to FIGS. 2-5), and theglucose level in the blood tested is displayed on the display 10 of thePDA 4, or transmitted through a speaker or otherwise to a user of thedevice shown in FIG. 1.

The PDA 4 is configured to HotSync with a PC for transmitting data to aPC. The PDA 4 may also transmit data by wireless RF and/or IR connectionto a remote or host client or server computer. The PDA 4 also preferablyhas internet connectability or is otherwise configured for logging intoa network for transmitting and receiving data from the network.

FIG. 2 shows a block diagram of electrical modules of the integratedglucose measurement module 2 and PDA 4 of FIG. 1. At the point of the invitro test strip slot 6 at the top of FIG. 2 is a strip interface 12including circuitry for connecting to an in vitro test strip for passinga current through blood applied to the strip. Glucose measurementcircuitry 14 is shown connected to the strip interface 12 for measuringone or more parameters indicative of a blood glucose level of the bloodapplied to the strip. An isolated power module 15 provides power to theglucose measurement circuitry 14 and strip interface 12 and ultimatelyto the test strip.

An isolation barrier 16 is shown for isolating the power at the modulefrom the power at the PDA 4. The isolation barrier 16 is provided toprotect the user from having a high current pass through his or her bodywhen the PDA 4 is in a HotSync cradle 18 and thus is connected to ACpower. Since an electrically conductive part of the integratedmeasurement module 2/PDA 4 system (i.e., a strip) contacts the patient,the system may be considered to have a “patient applied part” and wouldbe bound to comply with applicable standards (AAMI ES1, IEC60601-1-2,etc) for isolated patient connections. These standards containrequirements for a maximum amount of current that can flow in eitherdirection between the patient and an AC power line or ground with eitherthe module 2 or the patient in contact with 110% of line voltage.

When the glucose measurement module 2 is inserted into the PDA 4 and thePDA 4 is connected to it's HotSync cradle 18 as shown in FIG. 2, ACground is connected to the module 2. This connection is made because theground connection of the HotSync cradle 18 to the PDA 4 is connected toground at the computer to which the HotSync cradle is connected, whichis in turn connected to earth ground at the AC outlet. If AC voltage isapplied to the strip connector 12, a large amount of current would flowto AC ground through the module 2, PDA 4, HotSync 18, and/or computercircuitry.

Referring to FIG. 3 a, a module 20 connected to PDA circuitry 22 and nothaving the electrical isolation barrier 16 of FIG. 2 is illustrated. Apatient 28 is shown contacting a test strip 30, e.g., for applying bloodto the strip or for inserting the strip into the module 20. The patient28 is also contacting AC power 26 which also powers a computer 24. Thecomputer 24 is shown communicating with the PDA 22 through the HotSynccradle 18. AC ground is shown connected to the computer 24, the Hotsynccradle 18, the PDA circuitry 22, and the module 20. If the user 28became in contact with the test strip 30 and inadvertently came incontact with any earth referenced potential, large currents would flowthrough the user 28, and back to earth ground via this path. Conversely,if the module 20 or test strip 30 were to be inadvertently raised to ahigh potential reference to earth ground, again large currents wouldflow through the user 28. The risk in each case is electrocution of theuser 28 and the standards consider having the user 28 in contact withsignificant potentials a viable scenario. Should even very smallcurrents flow across the heart, e.g., there is significant risk ofcausing fibrillation.

In order to prevent this potentially dangerous situation, electricalconnections which come into contact with the user 28 at the stripconnector 30 are advantageously isolated from earth ground or AC inaccord with a preferred embodiment. FIG. 3 b illustrates the scenariodescribed above with respect to FIG. 3 a except that the module 2includes the isolation barrier 16 referred to above with reference toFIG. 2. The user 28 who is shown in FIG. 3 b in contact with AC power 26to the computer 24 is also contacting the strip 30 which is connected tothe module 2. In contrast with the scenario illustrated by FIG. 3 a, thestrip 30 is not connected to AC ground, and thus no currents passthrough the user 28.

This isolation barrier 16 is preferably created via a physical orotherwise insulating gap in the circuitry on the PC board or the module20. A preferred dimension of this gap is around 4 mm and is generallydictated by electrical safety standards.

Referring back now to FIG. 2, the glucose measurement circuitry 14 andstrip interface 12 are shown on the isolated side of the barrier 16.Power for this isolated circuitry is created by power transfer circuitry32, which is a transformer coupled, switching power supply according toa preferred embodiment. The transformer 32 bridges the isolation barrier16 and transfers isolated power 15 to the isolated side of the barrier16 from the PDA-to-module interface connector 34. For sufficiently lowpower consumption requirements, a capacitively-coupled supply would be aviable alternative power transfer circuitry 15. Switching controlcircuitry 36 is on the PDA (ground referenced) side of the isolationbarrier 16.

A glucose value is calculated by circuitry 14 on the isolated side ofthe barrier 16. The glucose value, status, and errors are communicatedacross the isolation barrier 16 preferably via a bidirectional serialinterface 38. Control commands may be preferably received from the PDA 4via this same interface 38. Serial communication lines of the serialinterface 38 bridge the isolation barrier 16 preferably viaoptoisolators (not shown, but see FIG. 5 and discussion below). Serialinformation is converted to parallel by serial to parallel conversioncircuitry 40 within the module 2 on the PDA side of the barrier 16, sothat the module 2 can communicate with the PDA 4. The PDA interface 42at the module connector 34 is parallel access directly to a PDAdata/address bus of PDA circuitry 44. This interface 42 includes controllines as well as power connections.

As an alternative to providing an electrical isolation barrier betweenmodule 2 and PDA 4, features can be incorporated into module 2 thatprevent it from being used at the same time that PDA 4 is connected to aHotSync cradle or cable, thereby eliminating the risk of passing highlevels of electric current through the cradle or cable to or from thepatient. This can be accomplished by providing an extended portion ofthe housing of module 2 that extends down along PDA 4 to interfere withthe attachment of a cradle and/or cable to PDA 4 when module 2 is firstattached thereto, or prevent the attachment of module 2 when a cradle orcable is already attached to PDA 4.

FIG. 4 shows an electrical circuitry schematic of a glucose measurementmodule for integrating with a PDA according to a preferred embodiment.The electrical schematic shown in FIG. 4 shows a strip connector 52 formaking electrical connection to a strip 8 inserted into the slot 6 ofthe module 2 of FIG. 1. Analog front end signal acquisition circuitry 54is shown for acquiring signals indicative of a blood glucose level inblood applied to the strip 8 (FIG. 1). A microprocessor 56 is shown forcontrolling the module 4. The microprocessor 56 receives isolated power(see element 15 of FIG. 2) as isolated voltage IVcc from an unregulatedvoltage at point 58 of the schematic of FIG. 4 appearing on the isolatedside of the barrier (which is the barrier 16 of FIG. 2), and regulatedthrough regulator 60.

FIG. 5 shows an electrical circuitry schematic of a PDA for integratingwith a glucose measurement module according to a preferred embodiment. Aconnector 62 for mounting the module 2 with the PDA 4 as shown in FIG. 1is shown next to a memory 64 for storing digital data. At the right inFIG. 5 is a universal asynchronous receiver/transmitter or UART 66. TheUART is on the non-isolated side of the barrier 16 of FIG. 2. The UARTsperform the serial to parallel conversion of element 40 of FIG. 2.

Data is transmitted serially from the glucose module 2 to the UART 66(or converter 40 of the module 2 of FIG. 2) through optoisolator 68.Data is transmitted serially from the UART 66 to the isolated side ofthe barrier 16 of FIG. 2 through the optoisolator 70. Data mayalternatively be transferred across the barrier 16 in parallel.Additional optoisolator components would be used for parallel datatransfer compared with serial transfer. Serial transfer is preferred andallows the module 2 to be smaller, more economical to manufacture andmore power efficient than if parallel transfer and additionaloptoisolators are used.

Power is transferred from the PDA 4 through the transformer(corresponding to the power transfer circuitry 32 of FIG. 2). Thetransformer is preferably a 1:1 transformer, and may be a step-down orstep-up transformer of a desired ratio. Through the transformer, poweras voltage Vcc is transferred from the non-isolated side of the barrier16 to the isolated side as isolated power 76. The power may be around3.3 Volts according to a preferred embodiment.

FIG. 6 a schematically shows a plan view of a glucose measurement module78 for integrating with a PDA (not shown, but see FIGS. 7 a-7 b)according to a preferred embodiment. The module 78 includes a mountingportion 80 and a specially shaped extension portion 82. When the module78 is inserted into a PDA and is mechanically and electrically attachedto the PDA and configured to transfer data to/from the PDA, the mountingportion 80 is within the PDA and the extension portion 82 protrudesoutside of the PDA.

The module 78 (corresponding to the module 2 of FIG. 2) is about 54 mmwide at the mounting portion 80 which plugs into the PDA 4 and scalesdown to around 23 mm at the end 86 of the extension portion 82 where thestrip 8 of FIG. 1 is inserted. The extension portion 82 itself measuresabout 54 mm in width at the other end where the mounting portion 80begins and the extension portion 82 is preferably about 28 mm long fromthe mounting portion 80 to the strip insertion end 86. The shoulder fromwhich the extension portion 82 narrows most drastically in about 8.5 mmin extent o the approximately 28 mm extent of the extension portion 82.The curvature from the shoulder is about 0.5 rho, which changesdirection at a curvature of about 0.5 rho and which changes directionagain at a curvature of about 0.6 rho to the strip insertion end 86. Asthe shoulder flattens out, it makes an angle of about 100° with theelongated direction of the module 78 from the strip end 86, or 80°looking at it from the direction of the mounting portion 80, which anglecan be varied somewhat while maintaining the shoulder and also thesmoothness of the rounding of the extension portion 82. The extensionportion 82 is shown symmetric, but may have an arbitrary curvature onone side the module 78 will be used by resting the extension portion ononly the side with rounded features as just described, i.e., it ispreferred there are no sharp corners on at least one side of theextension portion 82, and it is more particularly preferred that nosharp corners exist anywhere on the extension portion 82, nor even onthe mounting portion 80.

The mounting portion 80 connects electrically and for data transfer tothe PDA by preferably a 68 pin electrical connector 84 as shown in FIG.6 b for connecting to a complementary 68 pin male connector of the PDA,wherein the male and female configuration may be reversed or mixed. Thethickness of the module 78 is indicated as preferably around 19 mm. FIG.6 b schematically shows a rear view of the glucose module of FIG. 6 a.Although not shown, the module 78 attaches mechanically in place in thePDA receptacle by a pair of mechanical latches preferably on opposingsides, e.g., the left and right side in FIG. 6 a, of the PDA receptacle.

The extension portion 82 is particularly ergonometrically and/orarthopometrically configured so that a patient may insert a strip into astrip insertion slot (corresponding to slot 6 of FIG. 1) at the end 86of the extension portion 82, and so that the patient can contact thestrip with a drop of blood on the skin of the patient's body. The deviceis configured so that the patient may choose to use his or her arm, legor any convenient anatomic location including the finger. This isadvantageous because conventional systems often require application ofblood to the strip at the finger.

A feature of the shape of the extension portion 82 is its protrudingand/or telescoping trapezoidal profile. A utility design is provided atthe extension portion 82 of the module 78 that promotes easy andefficient manipulation of the glucose strip on the blood drop whether ifbe on or off-finger or at an alternate site. The PDA module designincorporates a telescoping trapezoidal profile that allows ease ofplacement and inhibits the PDA body from encroaching or otherwiseinterfering with the placement, e.g., at a patient's arm. At the sametime, the design is unobtrusive, streamlined and safe.

The telescopic and/or protruding trapezoidal profile of the moduleincludes generous radii on each of the compound edges shown in FIG. 6 a.The design allows easy and effective collection of a blood sample fromany approved site on the body. The design allows for ease of positioningthe module in the proximity of the blood drop and when actually placingthe glucose strip on the blood drop. The preferred radii of curvature ofeach of the three bends on each side of the slot 86 of the extensionportion 82 of FIG. 6 a are drawn to scale. The curvatures are selectedsuch that the PDA does not interfere with the blood application to thestrip, e.g., from a patient's arm, leg or other approved off-fingerlocation, and such that the shoulders of the extension portion 82 of themodule 78 may rest gently on the patient's arm while the blood isapplied, if the patient chooses, e.g., for support and/or stability. Inaddition, the design allows for a discreet and unobtrusive profileextending from the PDA. The design is compact and portable andpreferably does not include cumbersome and potentially hazardous cablesand extra attachments.

The extension 82 is preferably rounded in three dimensions or at leasttwo dimensions, e.g., as illustrated by the various views of thepreferred embodiment shown in FIGS. 6 c-6 f, and as mentioned,preferably has no sharp corners on at least one side which may be restedupon an arm or leg near an alternate site testing location, and fordisplaying information while testing on each arm for different testssuch as on different days, the extension 82 is preferably rounded onboth side and is particularly preferably symmetric as shown. FIG. 6 cschematically shows a bottom perspective view of the glucose module 78of FIG. 6 a with extension portion 82, mounting portion 80 and pinconnector 84. FIG. 6 d schematically shows a top perspective view of theglucose module 78 of FIG. 6 a with mounting portion 80, extensionportion 82 and strip insertion end 86. FIG. 6 e schematically shows aside view of the glucose module 78 of FIG. 6 a, indicating a totallength of about 85 mm, a thickness of about 14 mm at the extensionportion 82 and a thickness of about 0.9 mm at the mounting portion 80,wherein the extension portion 82 and mounting portion 80 couple in astaggered fashion with each portion 80 and 82 having an edge which looksout somewhat over the other. FIG. 6 f schematically shows a front viewof the glucose module of FIG. 6 a with the strip insertion portion 86showing at the end of the extension portion 82. The corners are roundedwith radius of curvature about 2.6 mm in the middle of the curve.

FIGS. 6 g, 6 h and 6 i schematically show another side view, a top viewand another rear view of the preferred glucose module with preferreddimensions shown in millimeters. Referring to FIG. 6 g, the mountingportion 80 of the module 78 has a thickness of around 14.3 mm, whichdiffers from the 0.9 mm thickness shown at FIG. 6 e. The thickness, aswell as the width and/or length, of the mounting portion 82 ispreferably set to adapt to the dimensions of the receptacle of thehand-held processing device (e.g., PDA, mobile phone, combinedPDA/phone, etc.) that the module 78 is to be connected, and thesedimensions will vary depending on the device, and so no fixed numericdimensions are necessarily universally preferred. The rounding of thestrip insertion end 86 of the extension portion 82 is shown as havingminimum radii of curvature of 9 mm on the bottom side and 2.5 mm on thetop side. Referring to FIG. 6 h, the rounding from the shoulder of theextension portion has a minimum radius of curvature around 12 mm, whilethe rounding which is opposite in direction as the rounding from theshoulder has a curvature radius of about 33 mm and that final roundingnear the strip insertion end 86 is about 22 mm at minimum. Referring toFIG. 6 i, a thickness of around 19.5 mm is shown for the rear view,which shows the pin connector 84, including the thickness of themounting portion 80 added with the staggered overlooking portion of theextension portion 82, as briefly described above, i.e., so that thestaggered overlook portion of the extension portion 82 is about 5 mm.

As shown in FIGS. 6 a-6 i, the extension portion 82 is rounded away fromeach side of the slot 86 in two orthogonal directions, and rounds fromthe slot 86 toward the mounting portion 80, corresponding to a thirddirection in which the extension portion 82 of the module 78 is rounded.This advantageous design prevents potential hazards such as pinching,lacerations, cuts or skin abrasions, during normal use and handling.

The module 78 serves as a housing for the strip connector, PC board andthe opto-isolation components, while not appearing bulky or obtrusive.As mentioned above, the module 78 does not include a display such as aLCD screen because the PDA display may be used as an advantageous PDAaccessory for displaying blood glucose levels without delay due to theintegrated design of the module 78 with the PDA (see FIG. 1). Thiscontributes to the compactness feature of the design, enabling themodule 78 to entend less than two inches beyond the end of the PDA, andas shown in FIG. 6 a, less than 1.5 inches and even below 1.2 inches.The module 78 at the extension portion 82 is around or less than 0.25inches thicker than the PDA. The module 78 weighs less than two ouncesand the preferred embodiment shown is around 1.1 ounces, while thedesign may be configured at less than one ounce. In contrast, if adisplay such as an LCD were included in the module 78, the module 78would likely be 50-60% longer, 0.25 inches thicker and be at least twoounces. The preferred module 78 thus does not have a display, and isthus smaller and lighter than if it did have a display, while theintegrated module-PDA system has full display capability. Obtainingpower to run module 78 from the PDA rather than from an internal powersource also contributes to the light, compact arrangement shown.

The module 78 shown and described with respect to FIGS. 6 a and 6 bincluding the telescoped, trapezoidal-shaped design has fully-radiusedshoulders in an advantageous profile. Some preferred radii and compoundangle values are shown in FIG. 6 a. From the slot 86, the design roundstoward the PDA at a preferred radius of curvature of 0.6 rho, thenrounds in the opposite direction away from the slot 86 at a preferred0.5 rho and then reverses its curvature again toward the PDA at apreferred 0.5 rho.

The module 78 advantageously mates with a PDA device and forms a single,hand-held unit for glucose measuring and data management. The mechanicaldesign shown in FIGS. 6 a-6 f allows measurements to be taken thatsuppress problems that might otherwise present themselves such asinterference by the bulky PDA in the blood application process, improperstrip placement and positioning, potential for injury, andobtrusiveness. The glucose monitoring strip may be positioned to applythe blood drop, while being attached to the module 78 which is itselfmounted into the PDA. The sheer size of the PDA in relation to themodule 78 does not inhibit the application process due to the design ofthe extension portion 82 such that the PDA body does not interfere withor become a hindrance to placement. The shape the profile of the moduleactually conforms to the shape of a body part such as an arm to which itrested, without presenting itself with an “arm-sliding” problem, as theuser positions the module 78 in close proximity to the blood drop. Therounded shape, generous radii and material selection reduce potentialhazards to the user, in terms of cuts, lacerations or skin abrasions.

Alternative designs would provide for a more pointed profile to themodule 78 to presumably provide easier access to the glucose strip orthe module 78 may be alternatively connected through a strip connectorand a flexible cable to allow flexibility of placement, independent ofthe PDA body. These alternative designs are not preferred, however, asthe size of the pointed profile may be limited by the size of the stripconnector and would likely not allow the user to effectively positionthe strip due to a lack of plastic real estate. Additionally, a flexiblecable, although affording flexibility of placement, would be cumbersomeand visibly obtrusive. The preferred design thus has the slightly widertip such as shown in FIG. 6 a and no cumbersome cable is used in thepreferred embodiment which includes the module 78 directly mechanicallycoupled with the PDA.

The module 78 and particularly the extension portion 82 are made of alow durometer material or thermoplastic elastomer facepad detail on bothsides of the enclosure, to act as a gripping surface for moduleinsertion and extraction, as well as afford the module a measure ofshock absorption. The material may preferably be a PC-ABS alloy or othernon-filled plastic resin.

FIG. 7 a schematically shows a side view of the measurement module 78 ofFIG. 6 a integrated with a PDA 4 according to a preferred embodiment. Anindication of an staggered overlook portion of the extension portion 82being 6.25 mm as opposed to the 5 mm shown about, again indicates thatthe dimensions of the module 78 can be varied to meet the specificationsof the particular hand-held device 4 being used. The mounting portion 80is shown inserted into the PDA 4 while the extension portion 82 is shownprotruding from the PDA 4. FIG. 7 b schematically shows a plan view ofthe integrated measurement module 78, with mounting portion 80 andextension portion 82, and PDA 4 of FIG. 7 a. As shown, the extensionportion 82, with length of about 28 mm, protrudes from the PDA 4 whilethe mounting portion 80 of the glucose measurement module 78, withoverall length of about 73 mm, is inserted within the receptacle of thePDA 4 (or other hand-held processing device, see above).

FIG. 8 illustrates generally a glucose data handling system softwareaccording to a preferred embodiment in block diagram form. FIG. 8 showsa measurement module 90 which receives a glucose strip 92 for measuringa glucose level of blood applied to the strip 92. The measurement module90 communicates with the PDA which may be running a Palm operatingsystem or other PDA operating system software. The measurement module 90is preferably configured to turn off nonessential electronics when nomeasurement is being made. The measurement module preferably includes amicroprocessor that controls internal timing, algorithms, resultcalculation and fault determination, among other responsibilities. Themodule 90 includes circuitry to connect the serial output of itsinternal microprocessor to PDA electronics including a mechanism forprogram initiation and data transfer. The module 90 also preferablyprovides electronic ESD protection on analog strip connector lines andflash memory for storage of meter firmware and associated userpreferences. The module 90 is preferably powered by the PDA, but couldalternatively include its own power source, such as button or AAA-sizebatteries. The module 90 includes electrical isolation between the stripconnector and the HotSync port.

The PDA communicates with a PC when the PDA is preferably HotSynced tothe PC. The PDA includes RAM as a temporary database for diabetesmanagement application data and/or programs and non-volatile memory forpermanent data and/or program storage. The measurement of the glucoselevel may however be advantageously performed when the PDA is notHotSynced to the PC, and the PDA includes many data processing featuresitself for managing data without support from the PC. For example,charts and/or graphs may be generated on the PDA display. The PC systemincludes standard peripheral devices such as a monitor 98, keyboard 100,CD-rom 102 and a printer 104.

FIG. 9 illustrates a hardware/software block diagram of an integratedglucose measurement module 2 and PDA 4 according to a preferredembodiment. The measurement module 2 shown includes a strip connector 52and analog front end electronics 54, such as those shown in FIG. 4. Themeasurement module 2 also shows a processor running firmware 110,wherein the processor may be as the processor 56 shown in FIG. 4. Theprocessor is shown having access to non-volatile data storage 112. Theisolation barrier 16 is shown wherein the above-mentioned components ofthe measurement module 2, i.e., the strip connector 52, analog front endelectronics 54, processor and firmware 110 and non-volatile data storage112, are on the isolated side of the barrier 116. PDA meter userinterface firmware 114 permits the module 2 to communicate with the PDA4. A serial to parallel interface, such as that shown in FIG. 2, is alsoshown in FIG. 9 for converting the serial data transmitted across thebarrier 16 using optoisolators 68, 70 such as thos described above withrespect to FIG. 5. An interface 116 is shown between the module 2 andPDA 4.

The PDA 4 is shown having a PDA RAM and non-volatile storage 118, a PDAprocessor 120, a PDA display and touchscreen 122 and a PDA serialinterface 124. The PDA is configured to HotSync to a PC system 96, suchas that described above with respect to FIG. 8, including a monitor 98,keyboard 100, CD-rom 102 and printer 104. The PC system shown in FIG. 9also includes a hard drive 126, a CPU 128 and a serial I/O 130 whichalternatively may be USB.

The data may be entered on the PDA 4. This data may be HotSynced to thePC 96. The data may also be entered on the PC 96 and reverse HotSyncedto the PDA 4. In the former case, e.g., the PC 96 would have anapplication stored in its memory for accepting this data. This PCapplication would display and print logbook data in various formats. ThePC application would also export data to various data processingapplications. The application may use a Microsoft Access Database or MDBformat, while the data on the PDA may be stored using the Palm PDBformat.

The user is preferably able to reverse HotSync data from the PC in orderto restore the data to the state it was when it was last HotSynced. Theuser might want to do this in the event the database on the PDA becomescorrupted. The PC application and database may store a complete historyof data that was entered on the PDA. The PDA user may choose to archivesome of the PDA data on the PC.

A conduit program may be used. The program may perform the followingsteps: (1) create a replica of the data stored on the PDA, on the PC;and (2) synchronize data from the PDA to the database on the PC. The twosteps may be performed in two separate conduit programs. Synchronizingthe data may include reading data from a PDB file and writing it to thePC database. Microsoft Visual Studio may be used for opening, readingand writing data in the PC database. The data may be read from the PDA,matched to data on the PC, format converted, and written to the PCdatabase. Similarly, data entered or modified on the PC may be matchedto data on the PDA. The data on the PDA may be updated to reflect thechanges made on the PC.

To match data from the PDA to the PC, unique ID numbers may be used inrecords on the two systems. These ID numbers may be created on the PDAas logbook records or on the PC as logbook entries there. The uniquenessof the ID numbers may be achieved by pre/post fixing the ID with anorigin code identifying PC or PDA, or alternatively perhaps a GUID.

To read data from a PDA file and write it to the PC database, it isrecognized herein that data in the PC database may be organized intotables, which may be organized into records, which may be broken downinto predefined fields. Similarly, at some level data will be organizedinto records with a consistent field structure on the PDA.

The conduit program reads the data from the PDA file(s) and writes itout to PC tables. The conduit program also reads data from the PC tablesand writes them out to PDA file(s). Various types of data conversion maybe used. For example, data residing in fields in the PDA file may beconverted from the format it exists in the PDA file to a formatcompatible with the PC and vice-versa. The logical structure of therecords in the two systems may be different. Tables may be created(either in code or in an external file such as a database) which definethe mapping of data in fields of one system to data in fields in theother. Data may be stored in temporary table(s) that may later besynchronized with main table(s) that contain a complete logbook history,or the conduit program may write to these tables directly.

FIG. 10 shows a data flow diagram of an integrated glucose measurementmodule 2 and PDA 4 according to a preferred embodiment. Current isflowed to a strip 8 from the measurement module 2 which, as mentioned,is powered by the PDA 4 as shown and described with respect to FIG. 5.The measurement module 2 includes a setup component 132, which themodule 2 communicates to the PDA 4, and a user preferences, calibrationcode and glucose log component 134. Component 134 serves to convert anelectrical reading, such as the current that passes through the blood onthe strip 8, to a glucose level, saves a glucose log, saves userpreferences, and provides status and error data to the PDA 4. Error datamay include glucose errors and charge errors. The PDA 4 is alsoconfigured to send user preferences and a calibration code to themeasurement module 2 for use or storage by the component 134.

The PDA 4 also receives firmware revision data, measurement state dataand temperature data from the measurement module 2. The measurementstate and temperature are preferably displayed on a display 10 of thePDA 4 or otherwise provided to a patient by sensory output such as audioor vibration output. The display 10 is preferably also configured tofunction with touchscreen software and electronics 135. The PDA 4includes a timer and power module 136, information about which is alsodisplayed. Data regarding the current time is also sent to the module 2from the timer and power module 136 of the PDA 4.

The PDA advantageously also includes an event database 138 and a userpreferences database 140. The event database 138 generally includesinformation relevant to diabetes management, such as glucose readings.Fields of an event may include time, data, event type. The glucose anderror data are stored to the event database 138 after the PDA 4 receivesthe data from the module 2. The event database includes a logbook whichcollects glucose, insulin, carbohydrate and exercise data and time. Thedata in the event database 138 may be graphed in many ways according tohelpful default or pre-programmed graphs or according to filtering andpreferences inputs from a user. Some exemplary graphs that may begenerated on the PDA display 10 from the event database and softwareloaded on the PDA without the PDA being HotSynced or otherwise connectedto a PC or other processing device. In addition, the data includingglucose data is automatically sent to the PDA 4 from the module 2 to bestored in the event database 138 where the data can be used to generategraphs that help a user such as a diabetes patient to track glucose andother information. The data measured by the module 2 does not need to bemanually entered by the user into a computer before the data can beprocessed into graphs and the like, or so that the PDA's own softwarecan process or analyze the data to provide useful data analysis to thepatient regarding the glucose and other information relating to thecondition of the patient. Software on the PDA also preferably includesinsulin and carbohydrate tools, and software for communicating with aPC. The user preferences database 140 may store user input such as unitsof measure, date and time format, an audible or otherwise sensory alertlevel, the language to be used and other user preferences.

The PC 96 such as that schematically shown at FIGS. 8 and 9 may haveadditional features. For example, the PC may be configured for viewingand printing the logbook stored on the PDA 4 and transferred to the PDA4. The PC may be configured to take glucose values and put them into adata management database of its own that may have the same or differentcapabilities as the event database loaded on the PDA 4. The PC would behelpful for backing-up data and for downloading applications programs tothe PDA and also for communicating with other computers over one or morenetworks. Additional data processing features of the system of thepreferred embodiment herein are set forth below with reference to FIG.11.

FIG. 11 shows a software data flow diagram of an integrated glucosemeasurement module 2 and PDA 4 according to a preferred embodiment. FIG.11 shows how four software applications according to a preferredembodiment interact and illustrate functions of these applications anddatabases that the applications are programmed to utilize. Theapplications include a meter application 150, a logbook application 152,a diabetes management application 154 and a data management application156. Each of these applications preferably runs on the PDA which hasbeen described above (e.g., see FIG. 10). These applications may alsoeach run on a PC to which the PDA is configured to communicate. Theapplications may be downloaded to the PDA or another device from the PCor a server or other digital data storage device such as a CD-rom ormagnetic disk.

FIG. 11 also shows a logbook database 158 and a carbohydrate (“carbo”)database 160. The databases 158 and 160 are generally electronic storedrecords. These may be separate databases or parts of a same database.The logbook and carbo databases may be part of the event database 138mentioned above with reference to FIG. 10. The logbook database 158 ispreferably utilized by each of the applications 150, 152, 154 and 156mentioned above and shown in FIG. 11, and includes automatic and manualglucose entries, insulin, exercise, meal and other data, and appliesuser preference filters. The carbo database 160 is preferably utilizedby the diabetes management application 154, and includes defaultcarbohydrate data and user entered data. Diabetes management generallyrefers to activities performed by an individual with diabetes toorganize and optimize aspects of life with diabetes such as medication,diet, and exercise that are involved in treating and managing thediabetic condition. The diabetes management application facilitatesthese activities for the diabetic. The data management applicationgenerally provide graphic representations and/or text summaries of datarelevant to diabetes management.

The logbook database 158 preferably includes time and date tagged eventswhich are automatically or manually stored such as glucose measurements,manually entered glucose readings, exercise records, insulin injectionrecords, meal time records, state of health records, note records, andmedication among others. The user may input entries to the logbookdatabase 158, e.g., that are derived from other glucose meters. Manuallyentered glucose readings may be flagged as user input rather than meterinput. The user may enter other items such as insulin amount, type, andtime period, meal times and carbohydrate values, exercise time, type,and degree of exertion (e.g., high, medium, low), state of health,comments and medications. These items may be available to the user froma predefined drop down list that can be edited and added to, or can bemanually entered. Data associated with a past event may be entered ormodified in the database 158 by the user. Events may be tagged with timeperiods.

Each application 150-156 is configured to process user inputs includingglucose measurements. For example, the meter application is configuredto process calibration code input, glucose readings and button presses.The glucose readings are advantageously automatically stored in thelogbook database 158 on the PDA according to the programming of themeter application 150. The logbook application 152 is configured toprocess stored log data and manual entries, and to store and retrievethe log stored log data and manual entries into and from the logbookdatabase 158, respectively. The diabetes management application 154 isconfigured to process a daily regimen and events such as exercise,meals, insulin dosages and times, etc. and to store and retrieve thedaily regimen and events into and from the logbook database 158,respectively. The diabetes management application 154 is also configuredto store and retrieve carbo data and manual carbo entries into and fromthe carbo database 160, respectively. The data management application156 is configured to process structured data with user filters applied,and to store and retrieve automatic and manual entry information intoand from the logbook database, respectively.

The data management application 156 may be configured to allow the userto view data summaries in graphical and text formats. The user may beable to select the length of time to be viewed. The user may also beable to set a default length of time to be viewed from within userpreferences. The user may be able to view a complete data set or filterthe screen display to show only a selected time period to view. The usermay be able to select the event type to be displayed, more than oneevent type may be selected to be displayed simultaneously. Glucosesummary statistics may be displayed by a selected date range and timeperiod. Both selected date range and time period may appear on thedisplay. The summary statistics may include the number of measurements,the highest measurement, the lowest measurement, the averagemeasurement, the standard deviation of the measurements, the percentageof measurements within the target range, the percentage of measurementsabove the target range, the percentage of measurements below the targetrange, and insulin and carbohydrate statistics summary. Graphicalsummaries may also be provided such as line graphs and pie charts (seeFIGS. 12-13). The user may be able to select a point on a line graph andsee the logbook entry associated with that point.

The diabetes management application 154 may be configured with diabetesmanagement tools such as carbohydrate tables, insulin tables, fastacting carbohydrate list, daily regimen (food and exercise patterns) andtarget glucose levels. The application 154 may process one or morecarbohydrate tables and a food database. The user may be able to chooseentries from a database listing carbohydrate values of foods per listedserving size. The user may be able to customize the food database byadding food items to the food database. The user may be able to tagentries as “quick picks”. The diabetes management application 154 mayinclude a lookup table containing the dose of insulin required to lowerglucose concentration by a known amount. The user may input insulindosages based on a health care professional's recommendations.

One or more of the applications 150-156 may be configured to issue“alerts”. These alerts may be warnings directed to the user that areaudible, or otherwise sensory such as by vibration, and displayed withgraphics and/or text using the display screen on the PDA. Alerts mayindicate that a planned activity is due to begin. Event markers may beused to indicate that the user makes an entry into the logbook 158 todesignate a specific condition or incident that relates to a specificblood glucose measurement such as meals, time before or after exercise,medication taken, sickness, feeling hypoglycemic, etc. The applications150-156, and particularly the diabetes management application 154, maybe used for self-monitoring of glucose in whole blood, and may be usedby people with diabetes and by healthcare professionals as an aid tomonitor the effectiveness of diabetes management.

The applications 150-156, and particularly the meter application 150,may be used to provide direction to a user taking a glucose measurementand control data flow to the logbook 158. For example, when the userinserts a test strip into the module, the module is programmed to checkthe strip and perform a self test. The display then indicates to theuser when to apply the blood. The user then applies the blood sample tothe strip. The measurement module monitors for fill (the PDA may, e.g.,beep on fill) and takes the measurement. The module is programmed tothen determine the glucose level and the PDA displays the result. Theglucose value is then automatically entered into the electronic logbook,i.e., without user intervention, and the meter waits for further userinput. Once the glucose measurement is complete, the meter application150 may be configured to relinquish control to one or more of the otherapplications 152-156.

FIG. 12 illustrates a line graph of blood glucose data generated by anintegrated measurement module and PDA according to a preferredembodiment. The data used to generate this graph is stored in thelogbook database. The line graph of FIG. 12 shows glucose levelsaccording to the date that the glucose level was taken. As shown, aglucose level that was recorded on November 5 at around 500 mg/dL islabeled as being “Hi” while a glucose level recorded on October 21 ataround 20 mg/dL is labeled as “Lo”. A range between around 80 mg/dL and140 mg/dL is indicated by dashed lines in FIG. 12 suggesting an optimalglucose level range.

FIG. 13 illustrates pie charts of blood glucose data generated by anintegrated measurement module and PDA according to a preferredembodiment. The data used to generate the illustrative graphs of FIG. 13is stored in the logbook database. All of the pie charts shown in FIG.13 may be displayed on a display screen 166 of the PDA at the same time,or one or more may be displayed at a single time. The graphs show thepercentage of readings that are below, within or above target. Forexample, chart (a) shows that overall 39% of the time the readings arewithin target or within the optimal glucose level range of FIG. 12.Charts (b)-(g) show the percentages of readings that are below, withinor above target pre-breakfast, pre-lunch, pre-dinner, post-breakfast,post-lunch and post-dinner, respectively. The user can understand his orher glucose level trends from these graphs.

As described above, the advantageous glucose measurement module 2, asschematically shown, e.g., at FIG. 1, including its rounded-contour,tapered-shape narrowed end portion protruding from an inset shoulder ofa connector end, and its composition, facilitates off-finger oralternate site testing. The strip 8, and/or any of various embodimentsthereof are described at PCT published application No. WO 01/33216 andU.S. patent application Ser. No. 09/434,026, which are assigned to thesame assignee as the present application and are hereby incorporated byreference. For example, the invention may use an electrochemicalcoulometric test strip such as the FreeStyle brand strip sold byTheraSense, Inc. of Alameda, Calif. The FreeStyle strip uses a so-called“side-fill” arrangement.

“Coulometry” is the determination of charge passed or projected to passduring complete or nearly complete electrolysis of the analyte, eitherdirectly on the electrode or through one or more electron transferagents. The charge is determined by measurement of charge passed duringpartial or nearly complete electrolysis of the analyte or, more often,by multiple measurements during the electrolysis of a decaying currentand elapsed time. The decaying current results from the decline in theconcentration of the electrolyzed species caused by the electrolysis.“Amperometry”, another method of electrochemically measuring glucose,includes steady-state amperometry, chronoamperometry, and Cottrell-typemeasurements.

While exemplary drawings and specific embodiments of the presentinvention have been described and illustrated, it is to be understoodthat that the scope of the present invention is not to be limited to theparticular embodiments discussed. Thus, the embodiments shall beregarded as illustrative rather than restrictive, and it should beunderstood that variations may be made in those embodiments by workersskilled in the arts without departing from the scope of the presentinvention as set forth in the claims that follow, and equivalentsthereof.

In addition, in the method claims that follow, the steps have beenordered in selected typographical sequences. However, the sequences havebeen selected and so ordered for typographical convenience and are notintended to imply any particular order for performing the steps, exceptfor those claims wherein a particular ordering of steps is expressly setforth or understood by one of ordinary skill in the art as beingnecessary.

1.-28. (canceled)
 29. A hand-held processing device, comprising: ahousing configured to be hand-held; a memory comprising one or moresoftware programs; a processor coupled to the housing, wherein theprocessor is configured to process data associated with monitoring ahealth condition using the one or more software programs; a display unitcoupled to the housing and in communication with the processor fordisplaying the data associated with the monitoring of the healthcondition; and a communication unit coupled to the housing and incommunication with the processor, wherein the communication unit isconfigured to receive data and/or software programs from a computerand/or network to the hand-held processing device.
 30. The hand-heldprocessing device of claim 29, wherein the health condition is diabetes.31. The hand-held processing device of claim 30, wherein the dataassociated with the monitoring of the health condition comprises dataindicative of an analyte concentration in a sample from a subject havingthe health condition.
 32. The hand-held processing device of claim 31,wherein the analyte is glucose.
 33. The hand-held processing device ofclaim 29, wherein the processing device comprises a measurement modulefor testing at least one physical parameter of a subject having thehealth condition.
 34. The hand-held processing device of claim 33,wherein the measurement module comprises a test strip receptacle coupledto the housing and in communication with the housing.
 35. The hand-heldprocessing device of claim 34, wherein the test strip receptacle isconfigured to receive a glucose test strip.
 36. The hand-held processingdevice of claim 29, wherein the display unit comprises a liquid crystaldisplay (LCD).
 37. The hand-held processing device of claim 29, whereinthe display unit comprises a touchscreen.
 38. The hand-held processingdevice of claim 29, wherein the hand-held processing device isconfigured to issue one or more communications to a user of thehand-held processing device.
 39. The hand-held processing device ofclaim 38, wherein the one or more communications are selected from anaudible communication, a vibratory communication, a graphicalcommunication and a textual communication.
 40. The hand-held processingdevice of claim 38, wherein the one or more communications indicate thata planned activity is due to begin.
 41. The hand-held processing deviceof claim 40, wherein the planned activity is user entry of dataassociated with the monitoring of the health condition.
 42. Thehand-held processing device of claim 41, wherein the data associatedwith the monitoring of the health condition comprises exercise data. 43.The hand-held processing device of claim 41, wherein the data associatedwith the monitoring of the health condition comprises dietary data. 44.The hand-held processing device of claim 43, wherein the dietary datacomprises meal-related data.
 45. The hand-held processing device ofclaim 44, wherein the meal-related data comprises meal time data. 46.The hand-held processing device of claim 44, wherein the meal-relateddata comprises carbohydrate value.
 47. The hand-held processing deviceof claim 31, wherein the analyte is glucose, and wherein the displayunit is configured to display a communication activatable when theglucose concentration of the sample indicates hyperglycemia,hypoglycemia, impending hyperglycemia, or impending hypoglycemia. 48.The hand-held processing device of claim 29, wherein the hand-heldprocessing device comprises a PDA, a mobile phone, or a combinationPDA/mobile phone.
 49. The hand-held processing device of claim 29,wherein the hand-held processing device is configured for USBconnectivity with a personal computer.
 50. The hand-held processingdevice of claim 29, wherein the network is a computer network.
 51. Thehand-held processing device of claim 29, wherein the communication withthe computer and/or network is wireless communication.
 52. The hand-heldprocessing device of claim 51, wherein the wireless communication is byRF and/or IR.
 53. The hand-held processing device of claim 29, whereinthe communication unit is configured for connection with the internet.54. The hand-held processing device of claim 29, wherein thecommunication unit is configured for communication with a personalcomputer, and wherein the processor is configured to synchronize data inthe hand-held processing device with data in the personal computer toproduce synchronized data.
 55. The hand-held processing device of claim54, wherein the synchronized data comprises time- and/or date-taggedevent data.
 56. The hand-held processing device of claim 29, furthercomprising diabetes management software configured to be accessed by ahealth care professional.
 57. The hand-held processing device of claim29, further comprising a database comprising data associated with themonitoring of the health condition, wherein the database is accessibleby a user of the hand-held processing device.
 58. The hand-heldprocessing device of claim 57, wherein the data associated with themonitoring of the health condition is event data.
 59. The hand-heldprocessing device of claim 57, wherein at least a portion of the dataassociated with the monitoring of the health condition is manuallyentered by the user of the hand-held processing device.
 60. Thehand-held processing device of claim 57, further comprising applicationsoftware configured to merge the data associated with the monitoring ofthe health condition with additional data specific for the user of thehand-held processing device.
 61. The hand-held processing device ofclaim 29, further comprising application software configured to storeand retrieve data associated with the monitoring of the health conditionsuch that the data associated with the monitoring of the healthcondition is accessible by a user of the hand-held processing device.62. The hand-held processing device of claim 61, wherein the applicationsoftware is configured to receive and store user-entered data associatedwith the monitoring of the health condition.
 63. The hand-heldprocessing device of claim 62, wherein the application software isconfigured to display one or more pre-defined drop-down lists from whicha user can select data associated with the monitoring of the healthcondition.
 64. The hand-held processing device of claim 61, wherein thedata associated with the monitoring of the health condition comprisescarbohydrate data.
 65. The hand-held processing device of claim 61,wherein the data associated with the monitoring of the health conditioncomprises exercise data.
 66. The hand-held processing device of claim64, wherein the hand-held processing device comprises a food databaseaccessible by a user of the analyte measurement system, wherein the fooddatabase comprises carbohydrate values for food items.
 67. The hand-heldprocessing device of claim 66, wherein the food database is customizableby the user of the hand-held processing device.
 68. The hand-heldprocessing device of claim 29, wherein the display unit is configured todisplay a recommended treatment to a user of the hand-held processingdevice.
 69. The hand-held processing device of claim 31, wherein thehand-held processing device further comprises application softwareconfigured to determine a dosage of medication based at least in part onthe indicated analyte concentration.
 70. The hand-held processing deviceof claim 69, wherein the analyte is glucose and the medication isinsulin.
 71. The hand-held processing device of claim 31, wherein thehand-held processing device further comprises application softwareconfigured to determine trending of analyte concentration based at leastin part on the indicated analyte concentration.
 72. The hand-heldprocessing device of claim 71, wherein the trending provides for a rateand/or acceleration of analyte concentration increase or decrease. 73.The hand-held processing device of claim 71, wherein the applicationsoftware is configured to communicate with the display unit such thatvisual indicators of analyte concentration trending are displayed to auser of the hand-held processing device.
 74. The hand-held processingdevice of claim 29, wherein the hand-held processing device furthercomprises application software configured to communicate with thedisplay unit such that a visual representation of data associated withthe monitoring of the health condition over time is provided to a userof the hand-held processing device.
 75. The hand-held processing deviceof claim 32, wherein the hand-held processing device further comprisesapplication software configured to communicate with the display unitsuch that a visual representation of glucose concentration over time isprovided to a user of the hand-held processing device.